Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/245
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Aminosyn-RF (Injection, Solution)
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Dosage Fat
emulsion coadministration should be considered when prolonged (more than 5
days) parenteral nutrition is required in order to prevent essential fatty
acid deficiency (EFAD). Serum lipids should be monitored for evidence of EFAD
in patients maintained on fat-free TPN. Adults: The objective of nutritional management of renal decompensation
is to provide sufficient amino acid and caloric support for protein synthesis
without exceeding the renal capacity to excrete metabolic wastes. A
dosage of 2.4 to 4.7 grams of nitrogen per day (from essential amino acids)
with adequate calories will maintain nitrogen equilibrium in patients with
uremia. If more nitrogen and calories are required in severely stressed patients
in acute renal failure who cannot eat, higher dosages may be administered
provided great care is taken to avoid exceeding limits of fluid intake or
glucose tolerance. In general, dosage should be guided
by fluid, glucose and nitrogen tolerances, as well as the metabolic and clinical
response. The rate of rise in BUN generally diminishes with infusion of essential
amino acids. However, excessive intake of protein or increased protein catabolism
may alter this response. The usual daily dose ranges
from 300 to 600 mL of Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection���renal formula) equivalent to 2.4 to 4.7 grams of nitrogen in 15.7
to 31 grams of essential amino acids. Adequate calories should be administered
simultaneously. Each 500 mL of Aminosyn-RF 5.2% mixed under sterile conditions
with 832 mL of Dextrose 70% will provide a solution of 1.95% of Aminosyn-RF
5.2% in 44% dextrose. This mixture provides a calorie-to-nitrogen ratio of
504:1. Electrolyte supplementation may be required. Elevated
phosphorus, potassium and magnesium levels generally decrease during treatment
with Aminosyn-RF 5.2%. Particular care should be taken in the presence of
cardiac arrhythmias or digitalis toxicity to assure that sufficient quantities
of these electrolytes are provided when necessary. Compatibility
of electrolyte additives to the mixtures of Aminosyn-RF 5.2% and hypertonic
dextrose must be considered and potentially incompatible ions (calcium, phosphate)
may be added to alternate infusion bottles to avoid precipitation. Children: Pediatric requirements for Aminosyn-RF
5.2% vary greatly depending upon growth, nutritional state and degree of renal
insufficiency. A dosage of 0.5 to 1 gram of essential amino acids per kilogram
of body weight per day will meet the requirements of the majority of pediatric
patients. Initial daily dosage of Aminosyn-RF 5.2% should be low and increased
slowly; more than one gram of essential amino acids per kilogram of body weight
per day is not recommended. The total volume of nutritional solution and the
rate at which it is administered will vary with the child's age, nutritional
and growth state, as well as the degree of renal failure. See Special
Precautions in Pediatric Patients foradditional information. Administration Aminosyn-RF
5.2% admixed with sufficient dextrose to provide caloric energy requirements
may be safely administered via a central venous catheter with the tip located
in the vena cava. Initial infusion rates should be slow,
generally 20 to 30 mL/hour for the first 6 to 8 hours. Increments of 10 mL/hour
for each hour are suggested up to a maximum rate of 60 to 100 mL/hour. If
administration rates fall behind the scheduled 24 hour dosage, no attempt
should be made to catch up to the planned intake. The patient's fluid,
nitrogen and glucose tolerance should be the governing factor of the rate
of administration. Uremic patients are frequently glucose intolerant especially
in association with peritoneal dialysis; insulin may be required to prevent
hyperglycemia. When hypertonic dextrose infusion is abruptly discontinued,
rebound hypoglycemia may be prevented by administering 5% dextrose. Parenteral
drug products should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit. WARNING: Do not use flexible container in series
connections.
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dailymed-instance:descripti... |
Aminosyn-RF 5.2%, Sulfite-Free, (an amino
acid injection���renal formula) is a sterile, nonpyrogenic solution
for intravenous infusion. Aminosyn-RF 5.2% is oxygen sensitive. The solution
contains the following crystalline amino acids: * Amount cited is for Lysine alone and does not include
the acetate salt. ** The minimum daily quantities needed
to maintain nitrogen balance in the healthy adult. (Rose, W.C., The Sequence
of Events Leading to the Establishment of the Amino Acid Needs of Man, Am
J. Public Health, 58:2020, 1968.) *** Histidine is
considered essential for patients in renal failure. Electrolytes and Product Characteristics Includes acetate from acetic acid used in
processing and from Lysine acetate. Adjusted
with acetic acid. Each 500 mL represents three Rose
Units of essential amino acids plus arginine and histidine. The
formulas for the individual amino acids present in Aminosyn-RF 5.2% are as
follows: The flexible plastic container is fabricated from a specially
formulated polyvinylchloride. Water can permeate from inside the container
into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions
in contact with the plastic container may leach out certain chemical components
from the plastic in very small amounts; however, biological testing was supportive
of the safety of the plastic container materials. Exposure
to temperatures above 25��C/77��F during transport and storage will
lead to minor losses in moisture content. Higher temperatures lead to greater
losses. It is unlikely that these minor losses will lead to clinically significant
changes within the expiration period.
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dailymed-instance:clinicalP... |
Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection���renal formula) is a mixture of amino acids specifically designed
for patients with acute renal failure who are unable to eat. The use of these
essential amino acids in the management of the uremic patient is based on
the minimal requirements for each of the eight amino acids essential in adult
nutrition established by Rose. In renal failure nonspecific nitrogen such
as urea, glycine, or ammonium chloride, are broken down in the intestine.
The ammonia formed is absorbed into the portal system and incorporated by
the liver into nonessential amino acids, provided requirements for essential
amino acids are being met. By this metabolic route, urea nitrogen contributes
to protein synthesis when the proper combination of essential amino acids,
sufficient calories and other required nutrients are administered. Thus,
the administration of essential amino acids to uremic patients, particularly
those who are protein-deficient, results in the utilization of retained urea
in protein synthesis, and may be followed by a drop in BUN and resolution
of many of the symptoms associated with azotemia. Aminosyn-RF
5.2% contains histidine, an amino acid considered essential for infant growth,
and identified as an essential amino acid for uremic patients. In
patients with potentially reversible acute renal failure who cannot eat, maintenance
of adequate nutrition may assist in reducing morbidity.
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dailymed-instance:supply |
Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection���renal formula) is supplied in 500 mL single-dose containers (List
No. 4166). Exposure of pharmaceutical products to heat
should be minimized. Avoid excessive heat. Protect from freezing. Store at
20 to 25��C (68 to 77��F). [See USP Controlled Room Temperature.]Avoid exposure to light. HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
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dailymed-instance:boxedWarn... |
SPECIAL PRECAUTIONS FOR CENTRAL
INFUSIONS ADMINISTRATION BY CENTRAL VENOUS
CATHETER SHOULD BE USED ONLY BY THOSE FAMILIAR WITH THIS TECHNIQUE AND ITS
COMPLICATIONS.
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dailymed-instance:precautio... |
CLINICAL EVALUATIONS AND LABORATORY DETERMINATIONS, AT THE
DISCRETION OF THE ATTENDING PHYSICIAN, ARE NECESSARY FOR PROPER MONITORING
DURING ADMINISTRATION. Blood studies should include glucose, urea nitrogen,
serum electrolytes, acid-base balance, blood ammonia levels, serum proteins,
kidney and liver function tests, serum osmolality and hemogram. Circulating
blood volume should be determined if indicated. If sepsis is suspected, blood
cultures should be taken. Clinically significant hypocalcemia,
hypophosphatemia or hypomagnesemia may occur as a result of therapy with Aminosyn-RF
5.2%, Sulfite-Free, (an amino acid injection���renal formula) and hypertonic
dextrose; electrolyte replacement may become necessary. In
order to promote urea nitrogen reutilization in patients with renal failure,
it is essential to provide adequate calories with minimal amounts of the essential
amino acids and to restrict the intake of nonessential nitrogen. Hypertonic
dextrose solutions are a convenient and metabolically effective source of
concentrated calories. Special care must be taken when giving hypertonic glucose
to provide calories in diabetic or prediabetic patients. Hypertonic solutions
should be administered through an indwelling catheter with the tip located
in the superior vena cava. When abrupt cessation of hypertonic dextrose is
required, monitoring for rebound hypoglycemia should be instituted. Essential
fatty acid deficiency (EFAD) is becoming increasingly recognized in patients
on long term TPN (more than 5 days). The use of fat emulsion toprovide 4���10%
of total caloric intake as linoleic acid may prevent EFAD. Fluid
balance should be carefully monitored in patients with renal failure to avoid
excessive fluid overload, especially in relation to cardiac insufficiency. SPECIAL PRECAUTIONS FOR CENTRAL
INFUSIONS ADMINISTRATION BY CENTRAL VENOUS
CATHETER SHOULD BE USED ONLY BY THOSE FAMILIAR WITH THIS TECHNIQUE AND ITS
COMPLICATIONS. Central vein infusion (with added carbohydrate solutions)
of amino acid solutions requires a knowledge of nutrition as well as clinical
expertise in recognition and treatment of complications. Attention must be
given to solution preparation, administration and patient monitoring. IT IS
ESSENTIAL THAT A CAREFULLY PREPARED PROTOCOL, BASED ON CURRENT MEDICAL PRACTICES,
BE FOLLOWED, PREFERABLY BY AN EXPERIENCED TEAM. SUMMARY
HIGHLIGHTS OF COMPLICATIONS (Also see Current Medical
Literature)<br/>Pregnancy Category C: Animal reproduction studies have not been conducted with
Aminosyn-RF 5.2%. It is also not known whether Aminosyn-RF 5.2% can cause
fetal harm when administered to a pregnant woman or can affect reproduction
capacity. Aminosyn-RF 5.2% should be given to a pregnant woman only if clearly
needed.<br/>Geriatric Use: Clinical studies of Aminosyn-RF have not been performed to
determine whether patients over 65 years respond differently from younger
subjects. Other reported clinical experience has not identified differences
in responses between elderly and younger patients. In general, dose selection
for elderly patients should be cautious, reflecting the greater frequency
of decreased hepatic, renal, or cardiac function, and of concomitant disease
or other drug therapy. This drug is known to be substantially excreted by
the kidney, and the risk of adverse reactions to this drug may be greater
in patients with impaired renal function. Because elderly patients are more
likely to have decreased renal function, care should be taken in dose selection,
and it may be useful to monitor renal functions. Aminosyn
5.2% contains no more than 25 mcg/L of aluminum. SPECIAL PRECAUTIONS IN PATIENTS WITH RENAL INSUFFICIENCY Frequent laboratory studies are necessary
in patients with renal insufficiency. In renal failure hyperglycemia may not
be reflected by glycosuria. Blood glucose must be determined frequently, often
every six hours to guide dosage of dextrose, and insulin should be given,
if required.<br/>SPECIAL PRECAUTIONS IN PEDIATRIC PATIENTS: Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection���renal formula) should be used with special caution in pediatric patients
with acute renal failure, especially low birth weight infants. Laboratory
and clinical monitoring of pediatric patients, especially those who are nutritionally
depleted, must be extensive and frequent. See Children section under DOSAGE AND ADMINISTRATION for additional information. Frequent monitoring
of blood glucose is required in low birth weight or septic infants as hypertonic
dextrose infusion involves a greater risk of hyperglycemia in such patients.
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dailymed-instance:overdosag... |
In the event of overhydration or solute overload, re-evaluate
the patient and institute appropriate corrective measures. See WARNINGS and
PRECAUTIONS.
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dailymed-instance:genericMe... |
isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine, arginine and histidine
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dailymed-instance:fullName |
Aminosyn-RF (Injection, Solution)
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dailymed-instance:adverseRe... |
Adverse effects include metabolic, fluid, electrolyte and
acid-base imbalances unless appropriate monitoring and corrective management
are accomplished during Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection���renal formula) therapy.
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dailymed-instance:warning |
Intravenous infusion of amino acids may induce a rise in
blood urea nitrogen (BUN), especially in patients with impaired hepatic or
renal function. Appropriate laboratory tests should be performed periodically
and infusion discontinued or nitrogen content reduced if BUN levels continue
to rise inappropriately. Administration of nitrogen
in any form to patients with marked hepatic insufficiency may result in serum
amino acid imbalances or CNS complications. Aminosyn-RF 5.2%, Sulfite-Free,
(an amino acid injection���renal formula), therefore, should be used
with caution in such patients. Solutions containing
acetate ion should be used with great care in patients with metabolic or respiratory
alkalosis. Hyperammonemia is of special significance
in infants, as it can result in mental retardation. Therefore, it is essential
that blood ammonia levels be measured frequently in infants. Aminosyn-RF
5.2% does not replace dialysis and conventional supportive therapy in patients
with renal failure. WARNING: This product contains aluminum
that may be toxic. Aluminum may reach toxic levels with prolonged parenteral
administration if kidney function is impaired. Premature neonates are particularly
at risk because their kidneys are immature, and they require large amounts
of calcium and phosphate solutions, which contain aluminum. Research
indicates that patients with impaired kidney function, including premature
neonates, who receive parenteral levels of aluminum at greater than 4 to 5
mcg/kg/day accumulate aluminum at levels associated with central nervous system
and bone toxicity. Tissue loading may occur at even lower rates of administration.
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dailymed-instance:indicatio... |
Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection���renal formula) is indicated only as an adjunct to management of patients
with potentially reversible acute renal failure who are unable to eat. When
infused with hypertonic dextrose as a source of calories and with added appropriate
electrolytes and vitamins, Aminosyn-RF 5.2% is suitable as an intravenous
source of protein in a parenteral nutritional regimen for such patients.
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dailymed-instance:name |
Aminosyn-RF
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